FIELD OF THE DISCLOSURE
[0001] The present disclosure relates to methods for analysing cardiovascular parameters
of an individual and devices used to carry out such methods.
[0002] More particularly, it relates to a method designed to assess parameters of the type
"pulse transit time", these parameters being determined from acoustic signals and/or
electrical signals emitted by the heart of such individual, and from responsive signals
sensed at a blood circulation sensor, which may be a blood pressure sensor or other
type of sensor. Likewise for one instance this kind of method, there may be used an
inflatable bladder comprised in a blood pressure cuff.
BACKGROUND OF THE DISCLOSURE
[0003] There is known devices that combine arterial pressure sensing means and electrocardiogram
sensing means, of the type for example disclosed in document
US20160235325, in which some attempts have been done to assess pulse transit time from ECG signal.
However, such method shows inaccuracy shortcomings since ECG signal fails to accurately
reflect the mechanical activity of the heart. Furthermore, acquiring pressure waves
at the wrist is not fully adequate to accurately detect some trouble located in the
arterial network close to the heart.
[0004] Therefore, the inventors have identified a need to enhance functionalities provided
by such methods and improve their accuracy.
SUMMARY OF THE DISCLOSURE
[0005] According to one aspect of the present disclosure, there is disclosed a method to
collect cardiovascular data relating to an individual user (U), in a system comprising
an acoustic sensor (4) configured to be coupled to the chest of the user, a blood
sensor configured to be placed at a predefined position at the user's body, an arterial
blood path (P) being defined from the heart to said predefined position, the method
comprising a set of steps named PTT procedure:
/A1/- acquiring acoustic signals at the acoustic sensor,
/A2/- acquiring of blood circulation signals at the blood sensor, image of instantaneous
blood circulation parameters prevailing at the predefined position,
/S1/- determining aortic valve closing instant T1(k) from acoustic signals,
/S2/- determining subsequently, from blood circulation signals, a characteristic point
(M2) occurring at instant T2(k),
/S3/- calculate a time difference, defined as ΔT(k) = T2(k) - T1(k)
/Sloop/ repeating, for each heartbeat, steps /S1/ to /S3/ until a stop criterion (SC)
is met.
[0006] Thereby, the electronic controller acquires acoustic signals, sensed by the acoustic
sensor, in timely conjunction with blood circulation parameters at the predefined
position, to determine therefrom for example a Pulse Transit Time (PTT) from the aortic
valve to the artery location of interest.
The term "predefined position" should be understood as a predefined location at an
artery vessel where the heart pulses reflect. The artery location of interest is not
necessarily at the vicinity of the skin, it can be located in depth into a user's
limb.
It should be understood that the so-called predefined position can be located at the
left arm, but it could also be somewhere else on the left arm, e.g. on the forearm,
on the wrist, somewhere else on the right arm of the user, including the wrist; it
is not excluded to implement the proposed method with pressure signals taken on a
lower limb of the user. Of course, calculation parameters to be used are to be adapted
in particular to the length of the arterial blood path (P) for each case.
The inventors have found that acoustic signals provide a good time marker for start
time in order to perform calculation of Pulse Transit Time (PTT). Particularly, the
closure of the aortic valve produces a sufficient noise to be properly captured.
The term "blood circulation parameters" can designate the blood local pressure, the
blood local speed, or even an image of both pressure and speed, prevailing at the
predefined position.
[0007] In one implementation, the system may comprise means for exerting pressure around
a limb of the user, at the predefined position, and the blood sensor may be a pressure
sensor, wherein blood fluid circulation parameters signals are pressure signals,
and wherein the method comprises, prior to step /S1/ :
/S0/ - exert a predetermined pressure (PT1)
And at step /S2/ the characteristic point (M2) is determined from a pressure signal
curve. With pressure signals, the method works well even though the artery vessel
is deep below the
skin.
In one implementation, the means for exerting pressure is a band (2) having an inflatable
bladder (53) configured to be placed at the predefined position, a pneumatic unit
with at least a pump (7), the pressure sensor being configured to be fluidly connected
to the inflatable bladder.
While aortic valve closure can be taken as a first time marker and, further, the corresponding
reflection/response in the pressure signal at bladder can be taken as a relevant second
time marker.
[0008] In one implementation, the predefined position is at the left arm (BG) of the user,
the band (2) is an arm band and is configured to be placed around the left arm of
the user.
It should be noted that, in the case of the left arm, the blood path at interest for
assessing the Pulse Transit Time (PTT) is rather short namely less than 40 cm and
concentrates on the main arterial network starting from the heart, which enables to
detect potential problems affecting aorta or other portion of the main arterial network
leading from the heart to the arm, (under this perspective the arm can be a better
location than the wrist or a leg).
Thereby, the electronic controller acquires pressure wave signals to determine therefrom
for example a Pulse Transit Time (PTT) from the aortic valve to the brachial artery.
[0009] According to one particular option, there is disclosed a method to collect cardiovascular
data relating to an individual user (U), in a system comprising an acoustic sensor
(4) configured to be coupled to the chest of the user, an arm band (2) having an inflatable
bladder (53) configured to be placed at a predefined position around a limb of the
user, for example at the left arm (BG), a pneumatic unit with at least a pump (7)
and a pressure sensor (61), configured to inflate and deflate the inflatable bladder,
an arterial blood path (P) being defined from the heart to the predefined position,
for example the left arm (BG) of the user, the method comprising a set of steps named
PTT procedure :
A1- acquiring acoustic signals at the acoustic sensor,
A2- acquiring pressure signals at the pressure sensor, image of pressure prevailing
at the brachial artery,
/S0/ - inflate the bladder at a predetermined pressure (PT1)
/S1/- determining aortic valve closing instant T1(k) from acoustic signals,
/S2/- determining subsequently, from pressure signals, a characteristic point (M2)
of the pressure signal curve occurring at instant T2(k),
/S3/- calculate a time difference, defined as ΔT(k) = T2(k) - T1(k)
/Sloop/ repeating, for each heartbeat, steps S1 to S3 until a stop criterion (SC)
is met.
The arterial blood path of interest is therefore mainly focused on the central arterial
distribution network; this improves the detection of potential problems affecting
aorta or other portion of the main arterial network leading from the heart to the
left arm.
The blood path at interest for assessing the Pulse Transit Time (PTT) is rather short
namely less than 40 cm and concentrates on the main arterial network starting from
the heart, which enables to detect potential problems affecting aorta or other portion
of the main arterial network leading from the heart to the left arm.
[0010] According to one particular option, the characteristic point (M2) of the pressure
signal curve is defined as a succession of a maximum apex (M1) and a minimum apex
(M2), said instant T2(k) being defined as the instant when said minimum apex occurs.
Faithfull and relevant time marker corresponding to arrival at the arm of the effect
of the closure of aortic valve is thus determined.
[0011] According to one particular option, the system comprises a set of contact electrodes
(3) for electrocardiographic sensing, configured to be brought in contact with the
skin of the user U, the method comprising the steps:
/A3/- acquiring ECG signals at the contact electrodes,
/S10/ - determining a characteristic QRS signal from ECG signals as a synchronization
signal (TO) reflecting heartbeat.
This helps to synchronize the analysis of acoustic and blood circulation signals.
[0012] According to one particular option, the aortic valve closing instant T1(k) is defined
as a second significant sound (B2) of the heartbeat.
Faithfull/relevant time marker corresponding to the closure of aortic valve is thus
determined.
[0013] According to one particular option, wherein at step /S1/, the aortic valve closing
instant T1(k) is determined as follows :
/S11/- identifying a first significant sound (B1) of the heartbeat, reflecting mitral
valve closing, just following QRS signal at instant T0,
/S12/- identifying a second significant sound (B2) of the heartbeat, reflecting aortic
valve closing, and record said second significant sound (B2) as instant T1(k).
This provides a simple and reliable method to determine instant T1(k).
[0014] According to one particular option, a significant sound is defined whenever a instantaneous
power of the acoustic signals exceeds a predetermined threshold (BS).
Noises can thus be disregarded.
[0015] According to one particular option, the method comprises, before the PTT procedure,
a preliminary set of steps named Blood Pressure procedure comprising the steps :
/Ph1/- start inflating the bladder,
/Ph2/- stop inflating the bladder (when no more pressure wave is identified),
/Ph3/- start deflating the bladder,
meanwhile are performed the following steps :
/PhS/ - determining Systolic Blood pressure (PTS), during inflating phase and/or deflating
phase
/PhD/ - determining Diastolic Blood pressure (PTD), during inflating phase and/or
deflating phase
This provides a blood pressure reference prior to carry out PTT procedure; abortion
of PTT can be decided if BP procedure is incorrect.
[0016] According to one particular option, prior to steps /S1/ to /S3/, the predetermined
pressure
PT1, providing pressurization for PTT procedure, is calculated with reference to the
diastolic pressure (PTD) determined at step PhD.
PT1 is therefore user dependent.
According to one particular option, the predetermined pressure
PT1 can be defined as a function of
PTD, for example with a value below PTD, this difference defined by a predefined offset;
in other words, PT1 can be equal to PTD - PTof, with PTof for example equal to 10
mmHg (10 Torr).
According to one particular option, the stop criterion SC is met after N heartbeats
for which steps S1 to S3 were carried out properly, N being comprised between 4 and
10.
PTT procedure can be short. Time duration can be defined by user or according to a
quality index criteria. Respiration/Breathing or other disturbances can be compensated
for. According to one particular option, at steps /A1/ and/or /A2/, acoustic signals
and/or pressure signals are digitalized are further filtered with a band pass filter
having a passing band range of [0,5Hz - 1kHz].
Continuous components and noises can thus be eliminated.
[0017] According to one particular option, during PTT procedure, pump is not energized and
a bleeder valve comprised in the pneumatic unit is not energized.
No noise from the device itself : no disturbance on acoustic signals.
According to one particular option, the method may further comprise :
/S41/ - calculate an average value ΔTav of ΔT(k), for k=j to j+N (with N being the number of heartbeats with effective PTT measurement),
/S42/- calculate a Pulse Wave Velocity (PWV) defined as PWV(k) = length(P) / ΔTav,
/S5/- assess therefrom an arterial stiffness (AS) of the user.
This provides a reliable rating averaged over several cycles.
According to one particular option, the
height (UH) of the user is taken into account at step /S42/, namely
length(P) = F1 (UH)
This provides a personal index, which is relevant whatever the length of the blood
path (which depends on the height of the user at first order).
According to one particular option, age (UA), gender (UG), and weight (UW), of the
user is additionally taken into account at step /S42/, namely
length(P) = F2 (UH,UA,UG,UW).
A cardiovascular index can be refined to faithfully reflect the arterial stiffness,
irrespective of user profile particulars.
According to one particular option, subsequent evaluations of Pulse Wave Velocity
are recorded for a particular user to form a history curve, and a deviation in said
curve is notified to said particular user.
The change in user habits can be detected by this means; said change can relate to
food intake, physical exercise, initial phase of a disease etc.
[0018] The present disclosure is also directed to a
system, device or
apparatus configured to carry out the above-mentioned methods and functionalities.
[0019] The present disclosure is also directed to computer readable medium encoded with
instructions that, when executed by a computer, cause performance of a method as described
above.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] Other features and advantages of the disclosure appear from the following detailed
description of one of its embodiments, given by way of non-limiting example, and with
reference to the accompanying drawings, in which:
- Figure 1 illustrates a general overview of a device according to the present disclosure
in a use configuration,
- Figure 2 shows a diagrammatic sectional view of the device in place on the left arm
of the user, and adjacent to the chest, for the generically defined embodiment,
- Figure 3 illustrates a mechanical configuration of the device in an open configuration,
according to a first embodiment,
- Figure 4 shows a diagrammatic sectional view of the device in place on the left arm
of the user, according to the embodiment shown in Figure 3,
- Figure 5 shows another diagrammatic sectional view of the device in place on the left
arm of the user, according to a second embodiment,
- Figure 6 illustrates a buckle configured to be used in co-operation with the arm band,
according to the second embodiment
- Figure 7 shows an exemplary block diagram of the device,
- Figure 8 shows a timing chart illustrating the method, at the heartbeat timescale,
- Figure 9 shows a timing chart illustrating the method at a larger timescale,
- Figure 10 illustrates the mechanical configuration of the device of the first embodiment
in a stowed configuration.
- Figure 11 illustrates a general perspective view of the device of the first embodiment,
- Figure 12 illustrates a general overview of the disclosed method,
- Figure 13 shows steps of the method regarding pressure signals handling,
- Figure 14 shows steps of the method regarding pulse transit time handling,
- Figure 15 shows a detailed sectional view of the armband.
DETAILLED DESCRIPTION OF THE DISCLOSURE
[0021] In the figures, the same references denote identical or similar elements. For clarity
purposes, some parts are represented intentionally not at scale with regard to other
parts. Also, some parts of timing charts can be represented intentionally not at scale.
[0022] Figure 1 shows an individual (also 'user')
U in a configuration where he/she is using a device
10 according to the present disclosure. The device (otherwise called "apparatus")
10 looks like a known brachial blood pressure sensing device (commonly named Blood Pressure
Monitor i.e. in short "BP Monitor"), but the device exhibits extended functionalities
as will be apparent below, so that the device can be called 'upgraded BP Monitor.
[0023] The user
U in question has, among other organs and limbs in his/her anatomy : a left arm
BG, a right arm
BD, a heart
H, a left hand
MG a right hand
MD.
[0024] Further the user in question has an aortic artery ('aortic arch') denoted
AA, a subclavian artery
SCA, an axillary artery
XA, a brachial artery
BA, belonging generally to the cardiovascular system of the user. Therefore a blood path
of interest noted
P is defined as the fluid conduit from the heart
H to a reference point at the brachial artery
BA.
[0025] Besides the left arm brachial artery as reference point, it should be understood
that the proposed method would properly work with another predefined position where
a band can be secured around a limb, either a lower limb or an upper limb.
[0026] The device
10 has a wireless communication capability to exchange data with a mobile entity like
a smartphone
85 (more generally a mobile device belonging to the user U like a tablet, a laptop....).
Such smartphone
85 may in turn exchange data with a remote entity like an Internet server
86 (more generally any resource available somewhere in Internet, not excluding a so-called
"cloud" resource).
[0027] The device
10 has either a small display or no display at all, since the user interface capability
provided by the smartphone
85 is fully relevant to support displays relating to the use and extended functionalities
of the device.
[0028] The device
10 is intended to be used at a home environment, for healthy people as well as people
suffering from some disease. It may be used in a medical environment but is particularly
suitable to be used by non-medical personnel, i.e. the user under measurement him/herself.
[0029] In the shown example, the device
10 comprises an armband
2 wrapped around the left arm
BG, a control unit assembly
1, and an acoustic sensor denoted
4.
[0030] The rest of the time the device is stowed, notably in a folded configuration as will
be seen later.
[0031] As illustrated on
Figure 1, the device comprises an armband wrapped around the arm i.e. the part of the upper
limb comprised between the shoulder and the elbow. However it is not excluded to use
the device elsewhere, at the forearm for example.
[0032] As illustrated on Figure 1, the device is installed on the left arm of the user.
However it is not excluded to use the device elsewhere, at the right arm for example.
[0033] As illustrated on
Figure 2, the left arm of the user includes a bone named humerus denoted
81, muscles (not specially shown), and the abovementioned brachial artery denoted
82. The humerus extends along an axis denoted
Z. The armband band
2, when wrapped around the arm BG, has a general cylindrical shape with a reference
axis substantially coinciding with arm axis
Z.
[0034] The armband has an internal wall denoted
26 intended to contact the arm's skin and to press against the arm. The armband has
an external wall denoted
27 on the opposite side of the band with regard to the internal wall
26.
[0035] In use configuration, the acoustic sensor
4 is located against the chest, i.e. against the left side of chest. Sound waves
4H emitted by the heart are sensed by a sensitive portion
41 of the acoustic sensor
4, the sensitive portion 41 bearing on the left-side chest, i.e. adjacent to the chest.
Handling of electrical signals transduced from acoustic waves
4H will be detailed later. It should be noted that acoustic waves 4H can be sensed by
the sensitive portion
41 without trouble through a light clothing, an underwear or the like.
[0036] According to one particular option, the device is further equipped with an ECG function,
i.e. ElectroCardioGraphic function.
[0037] For this purpose there are provided three contact electrodes
31, 32, 33, the three of them integrated in the device, without the need to have linking wires
like in most prior art devices.
[0038] The first electrode
31 is arranged on the internal wall
26 of the band and has a sensitive face oriented toward the skin of the arm. The first
electrode
33 is also arranged on the internal wall
26 and has also a sensitive face oriented toward the skin of the arm.
[0039] Each of the electrodes is formed as a thin pad of a surface comprised between 5 cm
2 and 10 cm
2; for example, the shape of the thin pad is somewhat arched to follow the standard
curvature of the skin of the arm.
[0040] In a particular option, first and third contact electrodes
31, 33 are disposed at distance from each other. Alternatively, first and third contact
electrodes
31, 33 can be arranged differently, for example one above the other or one aside the other.
[0041] Whenever the armband is pressurized, first and third contact electrodes
31, 33 are firmly pressed against the skin of the arm, thereby ensuring a fairly good contact
with a small electrical contact resistance. It should be noted that no gel is required
at the contact electrode contrary to conventional habits. Contact electrodes are to
be placed against the bare skin; however, thanks to the pressure, it is not excluded
to have a light underwear cloth between the skin and the electrodes.
[0042] The contact electrodes can be made of stainless steel, silver, or other coated materials
(coated with silver, chromium, gold, titanium or platinum), not excluding materials
coated by physical vapor deposition technique (known as PVD techniques).
[0043] It is to be noted that two electrodes might be sufficient, therefore the third electrode
33 is considered optional.
[0044] Regarding the second electrode
32, it is arranged around the external surface of the control unit assembly as best seen
at
figure 11. A conductive material forms a coating of at least a part of the control unit housing.
A metallic coating material (silver, titanium, chromium), are deposited by physical
vapor deposition technique (known as PVD techniques).
[0045] The second electrode covers the lower third of the cylinder, for example all around
the accessible circumference by the fingers of the user (see Fig 1). Therefore, it
is easy for the user to grab/seize the second electrode with a good electrical contact.
[0046] The above mentioned control unit assembly
1 has, in the shown example, an overall cylindrical shape with an axis denoted
Z1 (cf Figures 2,4,11). The control unit assembly
1 is fixed to the arm band
2. For example, it is fixed to the first portion
21 as explained below.
[0047] As seen on Figures, the general arrangement is as follows: the control unit assembly
1 extends from the external wall 27 of the band with regard to the main axis
Z along a direction denoted
X. In use configuration, when the chest of the user is nearly vertical,
X is substantially horizontal and in a front-rear direction.
[0048] In the illustrated case of a cylinder, the diameter of the control unit assembly
1, denoted
D1, is less than 40 mm, for example about 35 mm or even about 30 mm.
[0049] The acoustic sensor
4 has a center
44, which is referred to to define the transversal axis
Y, extends from the external wall 27 of the band with regard to the main axis
Z and passing through the center
44 of the acoustic head. In use configuration, when the chest of the user is nearly
vertical,
Y is substantially horizontal and in a left-right direction.
[0050] Angular distance between axis X and Y is denoted by angle α. In use configuration,
the angle
α is comprised between 90° and 140°, for example between 110° and 130°. As shown at
Figure 1, in use configuration, the right hand can conveniently seized the control
unit assembly
1 and the acoustic sensor is naturally placed against the chest of the user
U.
[0051] Regarding the acoustic sensor
4, according to one preferred option, it is formed as a piezoelectric transducer, which
can provide a very thin configuration; this piezoelectric transducer requires very
little space projecting from the external wall
27 of the arm band; this piezoelectric transducer requires no electronic supply, no
local electronic adaptation circuit.
[0052] Since the user naturally squeezes the acoustic sensor against the chest, the acoustic
sensor can properly work through a thin cloth like a T-shirt, a shirt, even two layers
of such cloth.
[0053] According to an alternative option, the acoustic sensor can be formed as a microphone.
[0054] In
Figure 2, a generic view of the armband is represented; this type of band can be a ring adaptable
in diameter/circumference. This kind of band can be inserted from the hand without
opening the ring, and slid up to the shown position on the arm. There may be provided
restriction means to decrease the play and lock the current position, before pneumatic
inflation.
[0055] An inflatable bladder
53 is provided. Such a compliant inflatable bladder is known per se in blood pressure
sensing apparatuses, and therefore not described in details here. At rest, the bladder
is arranged within the thickness of the band, as an internal layer.
[0056] There may be provided an armature
25, otherwise called
cuff holder, for structural support of at least a part of the band. The armature can be an arcuate
plastic part, made from a plastic material with good or high mechanical properties
(polypropylene, ABS, PVC, or the like), having a part-of-a-cylinder shape, or generally
an arcuate shape.
[0057] According to one particular aspect, both the bladder
53 and the armature
25 extend circumferentially along the major part of the active portion of the armband
2; such that in use, the bladder is surrounding practically all the circumference of
the arm of the user. Therefore, a homogeneous pressure is applied all around the arm
which is beneficial for the accuracy of the measurement and the quality of the contact
of the ECG electrodes
31,33.
[0058] As visible on
Figure 7, the control unit assembly
1 comprises a battery
17, an electronic controller
6 and a pneumatic unit
5. We note that no external wired connection is needed.
[0059] The pneumatic unit
5 comprises at least a pump
7 driven by an electric motor
57, a release valve
56 also called "bleeder valve"
56, and a pressure sensor
61.
[0060] The pneumatic unit
5 may optionally comprise a check valve
58. The release valve 56 may be an On/off valve or a progressive valve.
[0061] The control unit assembly
1 comprises an On/Off switch
16; the user may start a measurement, after having installed the armband, by actuating
the switch
16, pressing or touching according to various possible types of switches.
[0062] Further the control unit assembly
1 may further comprise a wireless interface
68 such as for example a wireless coupler (WiFi, Bluetooth™, BLE or the like), and a
display
67 already mentioned. The display
67 can be a LED display and or a dot matrix display; on this display, blood pressure
results can be displayed directly without use of the smartphone application.
[0063] There is provided a pneumatic hose
59 to fluidly connect the output of the pump to the bladder. It can be a one-way pneumatic
connection or a two-ways pneumatic connection (59,59'). According to one variant,
there is provided a specific sense line
59' decoupled from the pressurization line 59.
[0064] The pressure sensor 61 is in fluid connection with the inflatable bladder 53 through
the specific line 59', or through the common single 59 where applicable.
[0065] A first overview of the functionality of the device is given here, whereas it would
be described later in more detail with the help of
Figures 9 and 12.
[0066] A blood pressure measuring cycle is carried out first, and optionally, thereafter
a pulse transit time PTT measuring cycle is carried out. In the same timeframe or
separately, individual ECG signal analysis and/or phonocardiogram signal analysis
can also be performed.
[0067] For the blood pressure measuring cycle, the electronic controller 6 is configured
to first inflate the inflatable bladder 53 until the blood flow is greatly reduced
by the pressure exerted on the arm. During inflation, the analysis of the evolution
of pressure signals allows to infer the systolic pressure and the diastolic pressure.
The controller is configured to then progressively deflate the bladder
53. The progressive reinstatement of the blood pressure waves is also analyzed by the
electronic controller
6 to infer the systolic pressure and the diastolic pressure, in confirmation or replacement
of values deduced during the inflation phase.
[0068] Regarding the pulse transit time PTT, the electronic controller
6 determines a first characteristic instant and a second characteristic instant, and
the resulting time difference is used to calculate a pulse wave velocity to finally
issue an index representative of the arterial stiffness to the user.
[0069] Now are described in detail
embodiments and variants of the device structure.
[0070] According to the first embodiment, illustrated at
Figures 3, 4, 10 and 11, the band
2 comprises a first portion
21 and a second portion
22. The first portion
21 can be considered as the main portion since the control unit assembly
1 and the acoustic sensor
4 are affixed to this first portion
21, and furthermore this first portion houses the inflatable bladder
53, and optionally, the structural elastic armature
25 already mentioned.
[0071] The first portion
21 has a developed length denoted
L1. The second portion
22 has a developed length denoted
L2. The band has a height
H. Likewise, the armband
2 is made from a generally rectangular shape with a width corresponding to dimension
H and a length corresponding to added dimensions
L1 + L2.
[0072] For installing the arm band
2 around the arm prior to inflating, the user starts for example from a stowed configuration
depicted in
figure 10, the user unrolls the second portion
22 (see Fig 3) to make it possible to install the first portion around his/her left
arm BG. Thanks to the elasticity of the first portion, the first portion
21 can be opened so as to facilitate the insertion of the arm into the internal space
encompassed by the first portion. The user has to move away a little bit his/her arm
from the chest to do that.
[0073] It should be noted that this configuration allows installing the band/cuff without
inserting it along the forearm from the hand side.
[0074] Further operation involves the closing of the band 2 around the arm, and securing
this configuration prior to inflation.
[0075] A hook pad
29 is arranged at the external wall of the first portion
21 and a corresponding loop pad
28 is arranged at the internal wall of the second portion
22. Of course the reverse configuration loop/hook is also possible.
[0076] Hook pad
29 and loop pad
28 may have a general rectangular shape. Regarding the dimensions, the hook pad
29 can extend along all the height
H over a length of 5cm to 10cm; the loop pad
28 is longer, it also can extend along all the height
H but over a length of 10cm to 20cm.
[0077] After the user has placed the first portion
21 around the arm on the side of the chest as described before, he/she pulls the second
portion
22 toward the rear direction and then sticks the second portion 22 onto the first portion
21 by securing the loop pad
28 on the hook pad
29. The remaining unused end 22e of the second portion is left free.
[0078] Alternatively, according to a variant illustrated at
figure 11, where a special cutout 24 is provided, the remaining unused end
22e of the second portion can be folded around back into the front direction.
[0079] Fig 4 shows the device ready for inflation, the user presses the device onto his/her chest
to guarantee acoustic adaptation, namely proper collection of acoustic waves.
[0080] It should be noted that the length of the second portion together with the length
of the hook pad and the length of the loop pad allows the device to be adjusted to
a large variety of arm circumference and diameter
D2.
[0081] At
Figures 5 and 6, a second embodiment of the armband is represented, which also allows to instal the
band/cuff without inserting it from the hand. Again, the band
2 comprises a first portion
21 and a second portion
22.
[0082] In this embodiment, the device also comprises a buckle
9, also named 'return buckle' as seen on
Fig 6. The buckle can be manufactured as a bent metallic wire, shaped as a rectangular
loop. The buckle can also be made from plastic material with good or high mechanical
properties. Two long sides
9a, 9b are connected at their respective ends by two small sides, thereby forming a rectangle
with a length/height
H and a width denoted
L9.
[0083] The buckle is fastened to one circumferential end
21a of the first portion 21, at complete opposite from the other end
22e of the band 2.
[0084] For the assembly of the buckle on to the end
21a, it can be provide a seam in the band end, done after insertion of the loop buckle.
Alternatively, the loop formed by the buckle may have an openable slit
9s, with self locking retaining means (hook and the like).
[0085] For installing the arm band
2 around the arm prior to inflating, the user places the first portion
21 around the arm on the side of the chest and passes the second portion
22 into the buckle
9 toward the rear and then pulls the end of the second portion
22 toward the front direction, until the arm wraps without substantial play the arm.
Then the user sticks the returning portion
22c against the base
22b of the second portion to attach the attachment means, which results in the configuration
shown at
figure 5.
[0086] According to an aspect which is common to above embodiments, at least in part of
the band, as shown at
Figure 15, the band
2 comprises an internal layer
36 and an external layer
37 with an interval
2G available between the two layers. In the gap
2G, there may be provided the bladder
53, the armature
25, rivets
30 for fastening the contact electrode 31 and a connection wire
39. Other wires may be present, for connecting the acoustic sensor to the electronic
controller
6, and the third electrode.
[0087] There may be a single layer portion (i.e. without gap or interval), notably in the
distal end of the second portion 22.
[0088] The band
2 is for example made of strong fabric, woven or non-woven or synthetic material.
[0089] Generally speaking, the band
2 comprises attachment means, for fixing the size of the armband prior to inflating.
The attaching means may comprise one or more couple(s) of loop and hook pads.
[0090] Therefore, a 'continuous' unquantized adjustment of encompassed circumference is
made available, for any size of arm.
[0091] It should be noted that in the present specification, arm circumference
CIRC or diameter D2 are indifferently used, since we know that
CIRC = π x D2.
[0092] According to other possible solutions, there may be provided attaching means including
a releasable ratchet system, or a teeth system.
[0093] Regarding dimensions, the following preferences can be noted.
[0094] For a baseline device intended to encompass arms having a perimeter/circumference
comprised between 20cm and 42 cm, which represents most of the users :
L1 is for example comprised between 20 cm and 32 cm.
L2 is for example comprised between 15 cm and 25 cm.
H is for example comprised between 12 cm and 16 cm.
[0095] For an XXL device (special large dimension variant) intended to encompass arms having
a perimeter comprised between 40cm and 62 cm :
L1 is for example comprised between 40 cm and 45 cm.
L2 is for example comprised between 20 cm and 25 cm.
H is for example comprised between 14 cm and 18 cm.
[0096] This XXL variant can have a frusto-conical configuration, smaller diameter at the
elbow oriented end.
[0097] When the device is unused, as illustrated at
figure 10, it can be rolled up, whereby its size is less than 10cm x 10cm x H.
[0098] In the variant illustrated at
figure 11, the second portion 22 of the armband can exhibit a smaller height for its most distal
area; this option is delineated by the dotted line
24; in this case, when the free end
22e of the second portion is wrapped around the first portion at the location of the
acoustic sensor, the acoustic sensor 4 is still uncovered by the second portion. Therefore,
even though the user installs the device by wrapping it all around, this won't prevent
the device from working regarding the acoustic acquisition against the user's chest.
The device works as follows, as illustrated at figures 8, 9, 12, 13 and 14.
[0099] During a measurement, the patient's heart generates electrical impulses that pass
through the body at high speed. Also simultaneously the patient's heart generates
acoustic waves that pass through the body with a certain sonic speed.
[0100] These impulses/waves accompany each heartbeat, and the heartbeat generates a pressure
wave in artery network that propagates through the patient's vasculature at a significantly
slower speed. The blood path
P of interest has a certain length, let's say 30 cm to 40 cm according to the physical
characteristic of the individual under measurement. As will be seen in more detail
later, this length depends at first order on user's height denoted
UH.
[0101] Immediately after the heartbeat ventricular contraction, the pressure wave leaves
the heart and aorta, passes through the subclavian artery, to the brachial artery
along the path
P.
[0102] The ECG electrodes measure electrical signals which pass to an amplifier/filter circuit
within the control unit assembly. For example, a filtering circuit is provided before
the signal is digitized and entered into the microcontroller.
[0103] Within the controller, the signals are processed with an analog-to-digital converter
to form the ECG digitized waveform and then recorded together with the time of occurrence,
namely instant
T0. ECG waveform is named "QRS waveform" or "QRS complex" as sample shown at
Figure 8.
[0104] The acoustic waves are also band-pass filtered and amplified, for example after upfront
digitalization. A bandpass filter with cutting frequencies [0,5 Hz - 1kHz] is applied,
either in the analog font end before digitization or applied to the digitized acoustic
signal.
[0105] "QRS waveform"
91 is the top curve shown on timechart at
Figure 8. This waveform is known per se thus not described in details here. Instant
T0 corresponds in the illustrative embodiment to R apex, but another marker can be taken
alternately.
[0106] Aortic valve open/close state is also shown just beneath, signal denoted
92.
[0107] Mitral valve open/close state is also shown just beneath, signal denoted
93.
[0108] Just before aortic valve opening, the mitral valve closes; this produces a particular
sound which is reflected in the first significant sound named
B1 as shown on curve
95.
[0109] Further, after closing mitral valve and opening aortic valve, the ventricular volume
decreases as blood is ejected to the aorta. At the same time ventricular pressure
94 exhibits a rounded apex. Aortic pressure curve is shown and denoted
97.
[0110] Sound phonocardiogram corresponds to curve denoted
95 electrically reflects waves received at the acoustic sensor
4.
[0111] This curve
95 exhibits two characteristics sounds; the first sound denoted
B1 corresponds to the closing of the mitral valve, the second sound denoted
B2 corresponds to the closing of the aortic valve.
[0112] A
"significant sound", in the sense of the present disclosure, is defined whenever a instantaneous power
of the acoustic signals exceeds a predetermined threshold (BS), cf Fig 8.
[0113] It should be noted that sounds
B1 and
B2 exceeds
BS threshold.
[0114] Pressure wave at pressure sensor
61 in fluid communication with bladder
53 is shown at curve
96.
[0115] This curve
96 exhibits three characteristics apexes. The first apex denoted
M1 is a maximum apex; the second apex denoted
M2 is a minimum local apex; the third apex denoted
M3 is a maximum local apex.
[0116] Besides
M0 is the minimum value, just before the rise which is a consequence/response of the
arrival of the pressure pulse at the arm.
[0117] The second apex denoted
M2 is a marker corresponding to arrival of the effect of the closure of aortic valve
at the brachial artery within the arm band.
[0118] There may be defined a reference point in the arm, so that the ideal position for
the device can be notified to the user, for example distance from the elbow internal
fold, or another criterion.
[0119] Generally speaking, for the purpose of PTT,
T1 is defined as the instant of the maximum instantaneous signal power of the second
sound
B2 reflecting when aortic valve closes.
[0120] Generally speaking,
T2 is defined as the instant when second apex denoted
M2 occurs.
Blood Pressure procedure
[0121] This procedure is known in the art, and thus it is not described in details here.
Basically, it comprises the following phases:
/Ph1/- start inflating the bladder, inflation phase is denoted 71 at Fig 9, 'INFLATE' at Fig 12,
/PhD/ - determining Diastolic Blood pressure (PTD) during inflating phase
/PhS/ - determining Systolic Blood pressure (PTS), during inflating phase
/Ph2/- stop inflating the bladder 72 (when hardly no more pressure wave is identified),
/Ph3/- start deflating the bladder, deflation phase is denoted 73 'DEFLATE' at Fig 12,
/PhS/ - determining Systolic Blood pressure (PTSa), during deflating phase
/PhD/ - determining Diastolic Blood pressure (PTDa) during deflating phase
[0122] More precisely, the shape of the pressure waves are analyzed by the electronic controller.
During inflation
71, as shown at
Fig 9, the shape of the pressure waves evolves, and a predefined criteria on the waveform
makes the decision to record a first diastolic blood pressure
PTD, and another set of predefined criteria on the waveform makes the decision to record
a systolic blood pressure
PTS.
[0123] In a similar manner, during deflation phase, the shape of the pressure waves are
analyzed by the electronic controller. During deflation
73 the shape of the pressure waves evolves, and a predefined criteria on the waveform
makes the decision to record another systolic blood pressure
PTSa, and another set of predefined criteria on the waveform makes the decision to record
another diastolic blood pressure
PTDa.
[0124] It should be noted that pressure curved is shown after rectifying at figure 8, whereas
it is shown before rectifying at figure 9.
[0125] The second systolic blood pressure noted
PTSa can be regarded as a confirmation of the first systolic blood pressure noted
PTS. According to one example, an outputted systolic blood pressure can be an average
of the value PTS and PTSa.
[0126] Similarly, the second diastolic blood pressure noted
PTDa can be regarded as a confirmation of the first diastolic blood pressure noted
PTD. According to one example, an outputted diastolic blood pressure can be an average
of the value PTD and PTDa.
PTT Procedure
[0127] This procedure is adapted to determine as accurately as possible the pulse transit
time PTT.
[0128] It comprises the following phases:
/S0/ - inflate 75 the bladder at a predetermined pressure denoted PT1, the inflation bringing the pressure from the lowest value 74 to this predefined level PT1, detailed below
/S1/- determining the above-mentioned aortic valve closing instant T1(k) from acoustic signals,
/S2/- determining subsequently, from pressure signals, a characteristic point (M2)
of the pressure signal curve occurring at instant T2(k),
/S3/- calculate a time difference, defined as ΔT(k) = T2(k) - T1(k)
[0129] The predetermined pressure
PT1 can be defined as a function of
PTD, for example with a value below the diastolic pressure
PTD; this value may be defined by a predefined offset
PTof; in other words, PT1 can be such
PT1 = PTD - PTof, with
PTof for example equal to 10 mmHg (10 Torr).
[0130] According to one option, said characteristic point
(M2) is the above-mentioned local minimum apex, after first apex
M1.
[0131] Further, steps
S1 to
S3 are repeated until a stop criterion
SC is met. This stop criterion
SC can be defined according to different possibilities. One consists in predefined duration.
Another one consists in counting the number
N of heartbeat cycle ; for example
N is chosen between 4 and 20, for example between 6 and 12.
[0132] Overall duration for BP procedure is denoted
TMBP and duration for pulse transit time procedure is denoted
TMPTT. For example
TMBP is less than 10 seconds. For example
TMPTT is less than 12 seconds. According to a user configuration, selectively chosen by
user through the smartphone or locally by a double press on the switch
16, the user can choose to carry out only the blood pressure
or BP procedure
plus PTT procedure.
[0133] During PTT procedure, pump 7 is not energized and a bleeder valve comprised in the
pneumatic unit is not energized. Therefore, no intrinsic parasitic noise disturbs
the phonocardiogram analysis and therefore the PTT procedure and related calculation
is not disturbed by endogenous noise.
[0134] The electronic controller
6 computes therefrom a time difference, defined as
ΔT(k) = T2(k) - T1(k) for the heartbeat arbitrarily numbered
k.
PWV is the wave velocity along path P.
PWV is defined as
PWV = length(P) /
ΔT(k)
[0135] In practice, we prefer to rely on a successive series of
N measurements; in this condition, the method may comprise the following:
/S41/ - calculate an average value ΔTav of ΔT(k), for k=j to j+N
/S42/- calculate a Pulse Wave Velocity (PWV) defined as PWV(k) = length(P) / ΔTav,
[0136] The number N of effective PTT measurement can be chosen between 4 and 20.
[0137] The average value can be computed as follows

[0138] The
height (UH) of the user is taken into account at step S42, namely
length(P) =
F1 (UH)
[0139] Also any combination of
age (UA),
gender (UG), and
weight (UW), of the user may additionally be taken into account at step /S42/, namely
length(P) = F2 (UH,UA,UG,UW).
[0140] Arterial stiffness
AS can be defined as a function of
PWV. AS can be expressed as a rating between 1 and 10 ; it can also be expressed as an
equivalent age of the person. Arterial stiffness
AS is referred to as step
/S5/.
[0141] Fig 14 shows a summary of the above mentioned steps /S0/ to /S5/, with a repetition
until stop criterion (SC) becomes true (in other words criterion is met).
[0142] An optional step referred to as step /S6/ consists in transmitting the resulting
data and parameters to the smartphone 85 over the wireless link. Please note that
alternatively this transmission can be continuous all along the process, ECG signal
and/or phonocardiogram can be displayed in real time on the smartphone application.
Transmission of resulting data and parameters can also be done by packets, for example
one packet after blood pressure values are obtained (BP procedure) and another packet
after PTT Procedure.
[0143] A plurality of subsequent evaluations of Pulse Wave Velocity are recorded for a particular
user to form a history curve, and a deviation in said curve is notified to said particular
user.
[0144] It should be noted that the disclosed device has complete power autonomy; According
to a particular option, the device is formed as an integral unit, there is no external
wire, not external hose, therefore style and practicality are enhanced.
Summary of Cardiovascular parameters/functions that can be monitored by the device
:
[0145] As already mentioned, Diastolic blood pressure
PTD, and systolic blood pressure
PTS can be obtained from the blood pressure procedure, as a motion of blood pressure
cuff.
[0146] Also, as described before, PTT procedure allows to determine the arterial stiffness.
[0147] Also, heart rate
HR can be inferred from ECG signals 91, from phonocardiogram signals 95, or from oscillometric
signals 96, by measuring the average time separation between two heartbeats and deducing
therefrom the number of heartbeat and minute.
[0148] HR variability is also calculated, over at least three subsequent heartbeats.
[0149] Also, the device can perform ECG signal analysis, for detection of arrhythmia, as
known per se. Some anomalies in ECG signal 91 can be identified and associated to
a type of arrhythmia, such as arterial fibrillation.
[0150] Also, the device can perform a phonocardiogram analysis for detection of heart anomalies
responsible for so-called heart murmurs. In particular, some anomalies in phonocardiogram
signal 95 can be identified and associated to a valvulopathy, concerning any of the
mitral, tricupside, aortic, or pulmonary valves.
[0151] ECG analysis and phonocardiogram analysis can be carried out simultaneously with
the PTT procedure, or separately, namely before or after PTT procedure.
[0152] As illustrated at figure 12, ECG analysis can be performed all along and at any time.
According to one option, though ECG analysis is suspended whenever the electric motor
is energized to run the pump (this produce electromagnetic interference detriment
as to ECG signals).
[0153] Regarding the phonocardiogram analysis, it is for example carried out when no intrinsic
source of noise is present, for example during the constant pressure sequence for
PTT determination.
[0154] As shown at
figure 13, pressure signals are sensed by pressure sensor 61 and made available at the microcontroller
6. According to one option the microcontroller 6 digitizes the signal and then applies
a digital bandpass filter. For example a band range of [0,3Hz - 3kHz] or [0,5Hz -
1kHz] can be used.
[0155] The microcontroller
6 identifies wave pulses and determines values characteristics of said pulses, i.e.
amplitude, time position, apexes, derivatives, Q-factor,...
System, application and remote patient monitoring
[0156] The user can follow his/her own metrics on a smartphone application.
[0157] The device can be used by more than one user, selection of relevant user can be done
through the local display 67 or through the smartphone application. When actuated,
directly on the device, the activation switch 16 can be used to scroll across several
users names.
[0158] There is provided a Micro USB connection
69 for battery recharge and for up/downloading of data.
[0159] The smartphone application can display a history of measurement reports, which can
include BP, PTT, ECG signals, phonocardiograms.
[0160] It should be noted that phonocardiogram can be replayed via the smartphone application
and the loudspeaker/headphones coupled to the smartphone.
[0161] Smartphone application can issue time reminders for the user, so the user can measure
cardiovascular parameters regularly with the integrated device
10.
[0162] The integrated device
10 is configured to send an alert to the physician whenever some particular thresholds
are exceeded or when particular events are detected, such as an episode of arrhythmia.
Such thresholds regarding blood pressure can be defined either by the user him/herself
or by the physician/doctor.
[0163] The user can add the contextual note(s), such as medicine intake or a life circumstance
(just after wakeup, just before going to bed), to one or more measurement reports.
[0164] Measurement reports can be sent remotely to a server that can be accessed the physician/doctor,
so that the physician can analyze the patient's data from a distant location.
[0165] The system allows remote analysis of ECG signals; the user can receive in return
the diagnostic from the physician.
[0166] Although the drawings and the text above mainly focus on an example with an armband
placed around the left arm, it should be understood that the predefined position where
pressure signals are captured could also be somewhere else on one limb of the user,
for example at the forearm, at the wrist, somewhere else on the right arm of the user,
including the wrist; it is not excluded to implement the proposed method on a lower
limb of the user. Of course, parameters to be used are to be adapted in particular
to the length of the arterial blood path P.
[0167] Also, it is important to note that the acoustic sensor can be placed somewhere else
other than the left side chest of the user, the acoustic sensor may be provided with
an extension cord to electrically couple the acoustic sensor to the control unit.
[0168] Additionally, there may be provided a control unit implemented differently, not necessarily
adjacent to the armband.
[0169] According to
another embodiment, instead of an inflatable bladder, the system may include pressure exerting means
that are different from compressed air. For example, it can be two bladders filled
with water with a ballasting system. As per another example, it can be a mechanically
collar with controllable restraint. Although, solutions like a set of piezoelectric
actuators, or a collar with temperature dependent memory alloys are not excluded.
[0170] According to still
another embodiment, instead of a pressure sensor, at least one blood circulation parameter like the instantaneous
local speed can be sensed by a Doppler effect sensor placed adjacent to a surface
blood vessel.